Find out what Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022.
Read More![[video] Digital Health Innovators: Does your solution qualify as Software as a Medical Device (SaMD)?](https://images.squarespace-cdn.com/content/v1/563c7acce4b028323896cb89/1630919850100-SJ68VGMR0T2FN758NSE0/SaMD+for+RPM+and+RTM_blog+image_NGL.png)
If you’re in the Remote Patient Monitoring (RPM) or Remote Therapeutic Monitoring (RTM) space, then you’ll want to understand the criteria and opportunities for qualifying as Software as a Medical Device (SaMD)
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Join us for a webinar to explain the most recent regulatory and reimbursement changes around the Remote Patient Monitoring, Telehealth, e-Visit, and Virtual Check-in CPT codes, during COVID-19, and what those changes mean from a practical perspective.
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Welcome to January 2020! I am Tommy Miller, I am Senior Counsel, and life science practice lead here at Nixon Law Group. Today I want to walk you through what I think are the highs and lows of 2019, specifically related to the legislative and regulatory actions taken in the pharmaceutical and medical device space.
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The FDA has just issued four final guidance documents related to the 510(k) clearance applications for medical devices. The Guidance documents can be found here, and they describe the FDA’s current thinking on special 510(k) clearance programs such as the Abbreviated application and the newly established “Special 510(k)” program.
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Hospitals and medical device manufacturers will both benefit from the Centers for Medicare and Medicaid Services’ (CMS) finalization of the 2020 Inpatient Prospective Payment System (IPPS) Final Rule (“Final Rule”) scheduled to be published on August 16, 2019. In an effort to increase Medicare beneficiaries’ access to innovative medical technologies, CMS has finalized certain changes to the “new technology add-on payment” “(NTAP) application and payment processes under the Final Rule. This change is likely to encourage hospital adoption of new technologies, which is intended to spur innovation and additional investment in these technologies.
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Following its July 15th letter to Virginia Industrial Hemp Processors (“Processors”) notifying them of Governor Ralph Northam’s recent directive regarding the manufacture of CBD in Virginia, the VDACS Food Safety Program (the “FSP”) sent a letter to Processors on Friday, July 26th setting forth guidelines for Processors to follow when manufacturing cannabidiol (“CBD”) products intended for human consumption (the “Food Safety Letter”).
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The Virginia Department of Agriculture and Consumer Services (“VDACS”) Commissioner Jewel Bronaugh sent a letter (the “July Letter”) to all Virginia-registered Industrial Hemp Processors (“Processors”) on July 15, 2019 notifying the Processors that Governor Northam’s office has directed VDACS to “treat hemp-derived extracts intended for human consumption as approved food additives and to place qualifying Registered Industrial Hemp Processors under food safety inspection so that inspected and approved processors may manufacture a hemp-derived extract for human consumption.”
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The U.S. Food and Drug Administration is currently accepting requests from medical software developers to participate in a precertification pilot program that is scheduled to begin September 1, 2017. The program is aimed at developing precertification criteria for software companies that would allow approved companies to engage in a streamlined premarket review process for certain digital health products. The FDA will accept up to nine participants for the pilot program, which the Agency says will include both large, established software developers and small startup companies.
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